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GLOBAL UNITE 1100-20-400Recalls & reported problems

Depuy (Ireland) · GLOBAL UNITE COLLAR STANDARD SIZE 52 · Class 2 · Implant

All models of GLOBAL UNITE (91)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295004288), received between Sep 25, 2018 and Dec 14, 2020 — classified as 2 injuries.

8 other recalls cover devices cleared under the same FDA submission (K101996, K170748); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Joint Laxity1
  • Loss of Range of Motion1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT TOLD SURGEON THAT HE WASN'T HAVING A LOT OF PAIN BUT WASN'T GETTING THE ROM THAT HE HAD BEEN GETTING. THIS PATIENT HAD A LEFT HEMI SHOULDER REPLACEMENT DONE FOR A FRACTURE BACK ON (B)(6) 2015. THE SURGEON THOUGHT THAT MAYBE HE HAD OVER-STUFFED THE JOINT AND WANTED TO REMOVE THE HEAD/COLLAR AND PUT ON A SMALLER HEAD. THE SURGEON REMOVED THE HEAD/COLLAR AND TRIALED WITH A 44 HEAD. HE SAID THAT HE FELT THAT IT IMPROVED THE STABILITY. HE THEN CLOSED THE PATIENT UP AND WAS HAPPY WITH THE RESULT. THE SURGEON FELT HE NEEDED TO DOWNSIZE THE HEAD SO STABILITY AND LACK OF ROM WAS THE MAIN ISSUE FROM WHAT I UNDERSTOOD TALKING WITH THE SURGEON. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2015, DOR: (B)(6) 2020, LEFT SHOULDER.

    Patient problems: Joint Laxity; Loss of Range of Motion; Pain

    MAUDE report 11003597 ↗
  • InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION DUE TO INFECTION. UNKNOWN; DOI: (B)(6) 2018; DOR.

    Patient problems: Unspecified Infection

    MAUDE report 7905159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101996, K170748. One submission often covers many models, so check the product and lot details in each record.

  • Z-0488-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
  • Z-0483-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
  • Z-0490-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
  • Z-0485-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
  • Z-0484-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
  • Z-0487-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
  • Z-0486-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
  • Z-0489-2022 · Dec 7, 2021 · Terminated
    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices

All PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page